Needleless valve

ABSTRACT

A needless valve is described which avoids the suctioning problems of the prior needleless devices upon deactivation and which preferably provides a positive self-purging effect. The valve is self-purging at the end of an administration cycle, avoiding clogging of attached catheters or other devices, and ensures that substantially all of liquid received into the valve is delivered to the receiver. The valve is also extremely simple in design and easy to construct and assemble, since it consists of only three pieces. The valve has a base with a connector for fluid communication attachment to tubing or other device, a solid elongated fluid channeling rod, and an internal fluid flow conduit; a flexible hollow expandable and contractible plug fitting over and moveable along the rod; and a tubular housing fitting over the plug and attached to the base. When the valve is activated by insertion of a nozzle of a fluid source, the rod and plug wall cooperate so that as the plug retracts along the rod, it is stretched and its interior expanded. Upon deactivation, the plug contracts, the interior volume decreases, and the resiling plug wall forces residual fliud within the valve to be expelled through the outlet, purging the residual fluid from the valve. No negative pressure is formed, so no suctioning of blood or other fluid from a patient or receiver occurs.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention herein relates to valves and connectors, such as those usein medical liquid flow applications such as intravenous (IV)administration of medications. More particularly it relates toneedleless valves for such applications.

2. Description of the Prior Art

-   -   There are many instances, particularly in the medical field,        where quantities of liquid must be moved from a source of the        liquid to a liquid conduit system under restricted and usually        sterile conditions. A principal example is the administration of        medication or other liquids to a patient intravenously. When the        intravenous administration is to be conducted at periodic        intervals over a extended period of time, the conventional        practice is to insert a catheter into the patient's vein,        usually through the patient's forearm, and leave the catheter in        place with a portion extending out of the patient's arm and        terminating in a valve (receiver) for periodic connection to the        liquid source as required. The presence of the valve avoids the        necessity of using direct injection of the patient each time the        medication is to be administered, which would be both painful to        the patient and also increase the risk of infection each time        the skin was penetrated.

For many years, receivers of valves were constructed with a resealablemembrane, such as a rubber or other elastomeric plug, stretched acrossthe inlet end of the device, closing off the IV fluid conduit. When itwas time to administer medication or other fluid, the physician or nursewould use a conventional hypodermic syringe with a sterile hypodermicneedle which would penetrate the rubber plug and allow sterile injectionof the fluid in the syringe directly into the liquid conduit or cannula.Upon withdrawal of the hypodermic needle, the elastic rubber plug wouldresile and seal itself, maintaining the sterile condition of theinterior of the system.

Such practice, however, has numerous disadvantages. Repeated piercing ofthe plug with the hypodermic needles eventually damages the plugsufficiently that it cannot maintain the appropriate sterile seal.Further, since the valve/receiver devices are normally quite small, theplug is even smaller, often less than ½ inch (6 mm) in diameter.Therefore the person administering the medication had to take care inmanipulating the syringe so that the hypodermic needle would pierce therubber plug and not hit the other portions of the receiver, thepatient's arm, or even the hands or arms of the person himself orherself. To take the appropriate amount of care, of course, requiredsome period of time, thus reducing the number of patients a physician ornurse could serve in a given time period. In addition, it was notuncommon for hypodermic needles to break off in the plug during orbefore administration of the liquid, thus usually becoming lodged in therubber plug and requiring the administrator to take time to remove thebroken needle. Further, such breakage also commonly caused the loss ofall or a portion of the medication or other liquid in the syringe and,of course, not properly administered to the patient.

Such problems were particularly common in situations where the medicalpersonnel were required to act very rapidly, such as in emergency roomand emergency medical administration settings.

The accidental piercing of the skin of the doctor or nurse raisedcritical problems. If such occurred before administration of themedication to the patient, the medication, or at least a portion of it,was injected into the nurse or doctor, which not only deprived thepatient of the medication, but in fact might be quite harmful to thephysician or nurse. If the accident occurred after administration of thefluid to the patient, the hypodermic needle could easily be contaminatedby the patient's blood or other bodily fluid, thus being capable oftransmitting the patient's disease to the physician or nurse. While thiswas a severe problem at any time, it became a truly critical problem asvarious highly infectious or virulent diseases became more prevalent inthe population. The added presence of infectious diseases with extremelyhigh rates of mortality among patients, such as AIDS, gave priority todevelopment of devices which would eliminate the need for use ofhypodermic needles.

In more recent years, “needleless” connectors and receptors have beendeveloped and widely marketed. In systems using this type of device, thefluid dispenser (usually a syringe) is fitted with a blunt nozzle ratherthan a hypodermic needle. The blunt nozzle is designed to be receivedinto a corresponding receiver attached to the IV line or other fluidconduit. Within the receiver is normally a hollow tubular cannula, whichis a fixed member forming the extended end of the fluid conduitextending into the patient's veins. Sterility of the receivers isimportant so that transfer of the liquid from the syringe to the cannulaand IV fluid conduit can be conducted under sterile conditions.

While the “needleless” concept has been well known and is quite simple,implementation of the concept in practice has been quite difficult.Needleless connectors have, for the most part, been designed with ahollow flexible plug which fits over the cannula and which has aself-sealing slit or similar closeable opening in its exterior end. Theinterior end of the plug is anchored adjacent to the downstream end ofthe cannula (i.e. the end leading into the IV system and the patient'sarm). Since the cannula is made as a rigid elongated tube, as the nozzleof the fluid dispensing device is pushed into the receiver, it contactsthat exterior end of the rubber plug and forces that end inwardlyagainst the distal end of the cannula. The distal end of the cannulacontacts the slit at the end of the plug and forces the slit open, sothat the plug then becomes a sleeve as it is pushed inwardly along theouter surface of the cannula. Eventually, the distal end of the cannula,now being exposed, contacts the interior fluid transfer tube of thedispensing device as the nozzle of the dispensing device moves furtherinto the receiver. When this connection is made, the fluid can betransferred from the syringe directly into the cannula through which itflows onto the IV system in the patient's body. Such opening of thedevice is commonly referred to as “activation” of the “valve.”

Once the fluid is fully transferred, the nozzle of the dispensing deviceis withdrawn outwardly through the receiver, causing the flexible plugto resile and extend distally along the cannula until it passes thecannula end and returns to its “deactivated” position enclosing the endof the cannula with the slit again sealed. Examples of devices of thistype are shown in U.S. Pat. No. 5,065,783 (Ogle) and U.S. Pat. No.5,549,577 (Siegel et al.) and in published PCT application no. WO93/11828 (Lopez).

While such devices have worked well for the most part, they have beenfound to have some serious deficiencies. One of the most important isthe fact that upon deactivation and withdrawal of the nozzle of thesyringe or other fluid dispensing device, the compressed plug resilesback to its original position, thus increasing its internal volume backto its deactivated volume, thus creating a partial vacuum in the cannulaand attached catheter. This produces a suctioning effect which oftencauses the patient's venous blood to be drawn into the catheter where itremains and can clot, thus preventing flow through the catheter. When itcomes time to administer the next fluid dose, the plugged catheterprevents administration of the fluid. Remedying of the problem requiresthat the catheter be cleaned or replaced. This, of course, is a majorproblem in emergency situations, whether in an emergency room or when apatient on IV suffers some sort of relapse or seizure or other criticalcondition and medication must be administered through the IV withoutdelay. Even in the absence of an emergency, however, withdrawal of thedevice for cleaning of the catheter requires that the IV subsequently bereinserted into the patient. In ordinary situations this at leastrequires the time of a nurse and is a discomfort for the patient. Inmany cases, however, reinsertion is a problem that requires a doctor'sintervention, as for instance where an new acceptable insertion site isdifficult to find or the patient does not tolerate needle insertionswell. Thus reinsertion presents a significant cost event for the medicalteam and subsequently for the patient.

Other forms of connectors in needleless couplings have been described.These may have components within the coupling intended to hold the fluidflow conduit open against the tendency of flexible sleeves attached toone or the other end of a coupled tubing to compress and close the fluidflow path. A typical example is shown in U.S. Pat. No. 4,457,749(Bellotti et al.) in which a “spike” having a cruciform cross section isused to hold open a fluid path within the coupling as the two portionsof the tubing are joined together.

SUMMARY OF THE INVENTION

I have now invented a needless valve which avoids the suctioningproblems of the prior needleless devices and which, in fact, can bestructured to provide a positive self-purging effect upon deactivation.This device retains all of the favorable aspects of the needleless valvesystem for activation and administering the medication to the patient,but avoids all of the detrimental effects of the prior art devices thatoccur during deactivation. The present device is virtually impossible toclog, is self-purging at the end of an administration cycle, and helpsensure that substantially all of the medication dispensed from thesyringe is administered into the patient. The device is also extremelysimple in design and easy to construct and assemble, since it consistsof only three pieces. The device may be made in a variety of differentconfigurations, all of which provide the same self-purging action andclear flow path for the administered liquid.

The device of this invention is configured so that a core rod forces theplug to expand during activation in a manner not possible with the priorart devices, which causes the interior volume of the plug to increasesubstantially from its rest (deactivated) volume and opens a flow paththrough the valve for the administered fluid. Upon deactivation, theplug resiles and its interior volume returns to rest volume, closing thefluid flow path and displacing residual fluid within the valve, so thatthe residual fluid is expelled from the valve through its outlet intothe downstream conduit or unit, purging the valve and promoting use ofall of the administered fluid. In addition, such volume decreaseprevents occurrence of any partial vacuum in the valve, and in factusually creates a transient overpressure, which also assists in purgingthe valve of residual fluid. The structure thus maintains either apositive or neutral (i.e., non-negative) pressure at all times,preventing any suctioning of blood from a patient into an attachedcatheter, thus avoiding clogging of the catheter by formation of clotsin blood drawn into it.

In a broad embodiment, the invention involves a needleless valvecomprising a tubular housing having a fluid inlet end and a fluid outletend, a solid rod within the housing, and a hollow flexible plug withinthe housing and moveable along the rod, the hollow plug in response toinsertion of a fluid supply nozzle into the inlet end moving in onedirection along and cooperating with the rod to increase the volume ofthe interior of the plug and open a fluid flow path between the inletand outlet ends, and in response to withdrawal of the fluid supplynozzle from the inlet end moving in an opposite direction along andcooperating with the rod to decrease the volume of the plug interior,close the fluid flow path between the inlet and outlet ends and causeresidual fluid in the flow path to be expelled from the valve throughthe outlet end.

In another broad embodiments, the invention involves a needleless valvehaving a distal end and a proximal end, and comprising a base disposedat the proximal end and comprising a connector for fluid communicationattachment to a fluid flow tube, a solid elongated fluid channeling rodextending from a proximal end joined to the base to a distal end, and afluid flow conduit formed in the base and extending through theconnector into the proximal end the rod and disposed for the fluidcommunication with the tube; a flexible plug having a wall forming ahollow interior bounded by an inward facing surface; the plug fittingover the rod, being sealingly attached to the base and being moveablealong the rod between a first activated position and a seconddeactivated position; in the first activated position the rodmaintaining the plug in a form with the interior having a first largervolume, with the plug withdrawn from the distal end of the rod, andcreating a fluid flow path through the interior and along the rod; andin the second deactivated position the plug being in a form with theinterior having a second smaller volume with the distal end of the rodcovered by the plug and the fluid flow path being blocked by the wall ofthe plug; and a tubular housing fitting over the plug and extending fromthe distal end of the device to the base, at the distal end the housinghaving an elongated receiver for releasable fluid communicationreception of a nozzle of a fluid source, the receiver configured toguide movement of the nozzle along the receiver into contact with theplug, the plug moving between the first and the second positions inresponse to movement of and contact from the nozzle; such that movementof the plug from the first position to the second position in responseto insertion of the nozzle into the receiver causing the rod and theplug to cooperate to expand the plug and increase the interior volumeand open the valve to fluid flow between the source and the tube, andsubsequent movement of the plug from the second position to the firstposition in response to withdrawal of the nozzle from the receivercausing the plug to resile and the interior volume to decrease, closingthe valve to the fluid flow, displacing residual fluid within the valveand causing the residual fluid to flow from the proximal end of thevalve into the tube.

In another embodiment the invention also comprises a rod for aneedleless valve comprising a solid elongated core having a plurality ofcoaxial ribs extending outwardly therefrom.

Ribs made be made with a uniform width so that their extended edges arestraight, with continuously varying widths so that their edged formstraight or curved smooth tapers, or have discontinuously varyingwidths, so that their edges form one or more steps over the length ofeach rib. In one embodiment, the ribs terminate at the distal end of therod in a hollow annular member encircling the rod.

Additional features of the invention as well as descriptions of thevarious forms of the components will be set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the device of this invention, with theindividual components thereof shown in separated relationship;

FIG. 2 is an enlarged sectional view taken on Line 2-2 of FIG. 1;

FIG. 3 is an enlarged sectional view taken on Line 3-3 of FIG. 1;

FIG. 4 is an enlarged sectional view taken on Line 4-4 of FIG. 1;

FIG. 5 is a sectional view taken on Line 5-5 of FIG. 4;

FIG. 6 is a sectional view taken on Line 6-6 of FIG. 3;

FIG. 7 is a sectional view with the components of FIGS. 2, 3 and 4 shownin assembled relationship;

FIG. 8 is a view similar to FIG. 7, with the valve opened by attachmentof a typical Luer-Lok connector;

FIG. 9 is a sectional view taken on Line 9-9 of FIG. 7;

FIG. 10 is a sectional view taken on Line 10-10 of FIG. 8;

FIG. 11 is a sectional view taken on Line 11-11 of FIG. 8;

FIG. 12 is a perspective view of an alternative embodiment of flexiblevalve component;

FIG. 13 is a sectional view similar to FIG. 7 showing the alternativevalve component in closed position;

FIG. 14 is a sectional view taken on Line 14-14 of FIG. 13;

FIG. 15 is a view similar to FIG. 13 showing the valve component openedby insertion of a Luer connector; and

FIG. 16 is a sectional view taken on Line 16-16 of FIG. 15.

FIG. 17 is a perspective view illustrating another embodiment of acentral rod of the present invention.

DETAILED DESCRIPTION AND PREFERRED EMBODIMENTS

The device is best understood by reference to the drawings. For thepurposes of description herein, the following conventions of directionwill be maintained. The terms “upstream” and “downstream” will be withrespect to the normal direction of fluid flow during administration ofmedication or other liquid through the valve of the present invention toa patient or other receiver. This is indicated in FIG. 8 by the flowarrows 50 (upstream) and 52 (downstream). Similarly, the terms “distal”and “proximal” will be used with respect to the patient or otherreceiver, such that the upstream end of the device is also sometimesreferred to as the distal end, while the downstream end is alsosometimes referred to as the proximal end.

One embodiment of the overall device 2 is shown in FIG. 1, separatedinto three components: a base 4, plug 6 and housing 8. The principalfeatures of each of the parts may also be seen in FIG. 1. The base 4consists of a connector 10 which connects the device with the fluid flowtubing or conduit 48, usually through a separate connector 94, asillustrated in FIG. 8; a radial flange 12, which serves as a seat forattachment of the plug 6; and an elongated rod 14 which, as will bedescribed below, cooperates with the plug 6 to provide the unique anddesirable operating features of the present invention.

The plug 6 has a seating gasket 16, a compressible mid-section 18 whichusually folds into a configuration similar to a bellows, and, at thedistal end 20, has a closeable slit or similar opening 22. The housing 8has a wide diameter expansion portion 24, a coupling ring 26 which,during assembly, is bonded to the flange 12 to retain the device as asingle unit and a receiving portion 28, the distal end 30 of which canbe configured as shown with threads 32 to join with correspondingthreads of a liquid dispenser to couple the two together.

FIGS. 2, 3 and 4 show respectively the housing 8, plug 6 and base 4 incross-section to facilitate understanding of their operations andfunctions. Considering first FIG. 4, the base 4 is formed of theaforementioned coupler 10, flange 12 and rod 14. As will be seen fromFIG. 4, the coupler 10 is has an annular form with its inner wall 34formed into threads or ribs 36 to allow it to be attached to acorresponding threaded end of coupler such as 94 as will be describedbelow. Centrally disposed within the annular shaped coupler 10 is ahollow tapered cylinder 40 which has fluid flow channel 38 extendingthrough it. Cylinder 40 is an extension of the flange 12 and rod 14 sothat it will be desirable for the entire base unit to be molded as asingle piece of rigid material, commonly plastic but also possibly ofmetal. The fluid flow conduit 38 continues as conduit 42 through thecenter of flange 12 and terminates as a conduit 46 within the proximalend 44 of rod 14. Fluid flowing downstream along rod 14 from the liquiddispenser 116 during activation of the device 2 thus enters the fluidconduit 46 through the openings 146, flows through aperture conduit 42through flange 12, and on through the channel 38 into coupler 94 andeventually into tubing 48 as shown in FIG. 8. The extension of cylinder40 beyond the proximal end of the base 10 facilitates insertion into thecoupler 94 or (in the absence of such a coupler) directly into, forexample, tubing 48. Tubing 48 may be substituted for by other devices towhich the valve is to be attached, such as direct coupling to a storage,test or reaction vessel or to a measuring instrument.

A preferred embodiment of a plug 6 is shown in FIG. 3. The plug 6 ismade out of a flexible material, usually a rubber or a polymericelastomer. In the embodiment shown the plug has a flange 16 which has aflat base 54 to allow it to seat against the corresponding flat distalface 56 of the flange 12 on the base 10, as shown in FIGS. 7 and 8. Themost proximal section 18 may be scored with groves 58 on the interiorand exterior to permit bellowing or other folding of the section as theplug is compressed and moved posteriorly during activation, as bestillustrated in FIG. 8. (Another embodiment of the plug 6 will bediscussed below, which has a different form of section 18.) In otherembodiments the flange 12 may be eliminated and other means, such as agripping or adhesive-coated surface (not shown) provided to which theproximal end of plug 6 is secured.

In the preferred embodiment shown in the drawings, the plug 6 also hasan intermediate section 60 which can be expanded, but which does notnormally flex, fold or compress as extensively as section 18. Both theexpansion and compression of section 18 and the expansion of section 60contribute to the self-purging action of the device 2 as will bedescribed below. The distal portion 62 of the plug 6 extends outwardlyjust past the tip 64 of rod 14 and normally has a somewhat thicker wallthan do sections 18 and 60 to accommodate the opening and subsequentclosing of slit 22 in the distal end 20 and to resist buckling of theend 20 when the unit is deactivated. Preferably the slit 22 will beterminated on the interior side of the plug 10 by a “duck bill” flange66 which assists in causing the slit 22 to resist leakage when internalpressure is present during deactivation.

The housing 8 is a simple rigid shell of plastic or metal, which isintended to fit over the plug 6 and attach to flange 12, thus lockinggasket 16 in position, as best shown in FIGS. 7 and 8. The inner portionof coupling ring 26 of housing 8 is configured with a generallysemi-circular channel 70 incorporated within it, both of which areconfigured to accommodate the corresponding base 72 and lip 74 of gasket16. When the connecting ring 26 is seated against the flange 12 of base4, preferably aligned by groove 76 into which rib 78 fits, and the twoare sealed together as by a conventional adhesive or by heat, ultrasonicor RF welding, the flange 16 of the plug 6 is firmly held against theflange 12 so that the plug cannot be displaced, and also to provide afirm base for subsequent return or resiling of the plug 6 upondeactivation.

The interior of section 24 of the housing 8 is configured to have asubstantially greater diameter than the deactivated rest diameter ofsection 18 of the plug 6, as indicated in FIG. 7, creating an annularspace 80 into which the portion 18 can expand as it is compressed toform the generally bellowed configuration shown in FIG. 8.

The rod 14 can have a number of different configurations, all of whichare intended to cause the plug 6 to expand outwardly during activation,thus creating the expansion of the elastic plug and increase of itsinterior volume, so that the plug 6 upon deactivation will return orresile inwardly, decreasing its interior volume and thereby purgingfluid from the fluid flow space 82 along the rod 14. The rod 14 can begenerally described as having a solid core 84 which terminates in ablunt or rounded tip 64 and which has extending radially outwardlytherefrom a plurality of ribs 86 (and perhaps also 86′). The ribs 86 mayhave various configurations which will cause the plug to expand andwhich will prevent prolapsing of the plug during activation. Forinstance, in various embodiments, an elongated rib may be uniform widthover most of its length (with preferably a transition curve or slope atits distal end, to facilitate movement of the end 20 of plug 6 along therod and rib), or it may have a continuously varying width, so that ithas a straight or curved tapered profile, or it may have widths thatvary discontinuously along its length, so that it has a stepped profile.It is preferred that for ribs in which the widths vary, eithercontinuously or discontinuously, the widths increase from distal toproximal ends, so that no recess or shoulder is formed upon which aportion of the interior of the plug wall could become snagged,preventing or impeding return or resiling of the plug upon deactivation.In yet another alternative, shown in FIG. 17, the proximal ends of theribs 86 may terminate in a hollow annular member 68 which serves tomaintain the maximum expansion of the plug 6 during activation.Conveniently this annular member 68 will be circular, but polygonalshapes are also usable, although polygons of less than six, and probablyless than eight, sides should probably be avoided, since they may beunduly angular and tend to impede resiling of the plug upondeactivation.

There may be any convenient number of ribs and they may be disposed atany desired orientation to each other around the circumference of therod 14. However, normally there will need to be at least three ribs 86,preferably equally spaced at 120° from each other, in order to ensurethat the elastic plug 6 is stretched to form a space 82 of appropriatevolume. Typically there will be four ribs 86 in a cruciform shape asindicated in FIGS. 9 and 10; although a larger number of ribs, such aseight as shown in FIG. 5, may also be used. It is also possible, andusually preferred, to have different numbers and lengths of ribs on thesame rod 14, as illustrated in FIGS. 1 and 5, where the added ribs 86′are interspersed between the principal cruciform ribs 86 but areforeshortened in axial length and extend distally only as far as thelength of the widest section of each rib 86. The added ribs help supportthe extended plug wall and prevent prolapse of unsupported portions ofthe wall and expansion increases and the wall thickness is thinned bystretching. Given the small size of the device and the desire tomaximize the flow channels, it is considered that eight to ten ribs areprobably the maximum practical number, with four, six or eight ribsbeing preferred, and other numbers (both between three and ten andgreater than ten) being possible. Use of an even number of ribs as shownin the illustrations is preferred since it is easier to mold symmetricalribs equally spaced than to mold an asymmetric configuration as would bepresent with and odd number of ribs. Further, the number of width stepsmay be two or three as shown or may be more, although again the smallsize of the device acts as a practical limitation on the number of widthsteps of the ribs 86 which are either feasible or desirable. Analternative embodiment of the plug 6 is shown as 6′ in FIGS. 12-16. Inthis embodiment, the plug 6′ is configured with an expanded downstreamsection 18′ which substantially replaces sections 18 and 60 in theconfiguration described above. The section 18′ may be somewhat bulbousor it may approximately conform to the shape of the rod 14 (shown inthese Figures with an alternative form of the ribs designated as 86″),with the plug 6′ having conforming hollow ribs 88. The operation of thisalternative plug 6′ is illustrated in FIGS. 13 and 15. In thedeactivated state, shown in FIG. 13, the plug is essentially in theshape shown in FIGS. 12 and 14. Upon activation by the nozzle 90 of aliquid dispenser, the bulbous section 18′ with ribs 88 expands outwardly(as shown in FIGS. 15 and 16) into space 80 and leaves an enlarged openspace 92 between the rod 14 and the interior wall surface of the plug6′. Upon deactivation the plug 6′ resiles or is caused to return to theconfiguration shown in FIG. 13.

It will be evident to those skilled in the art that there are, ofcourse, other configurations of the plug 6 other than that of 6′, whichwill provide equivalent expansion of the plug and increase of itsinterior volume during activation, and guide the subsequent resiling ofthe plug and decrease of its interior volume to produce the uniqueself-purging effect present in the claimed device. It is intended thatall such configurations are to be considered within the scope of thisinvention as defined in the appended claims.

The operation of the invention can best be understood by reference toFIGS. 8, 10 and 11. In a typical application, device 2 is attached to aLuer-Lok™ coupler 94. Coupler 94 is formed with a hollow cylindricalconnector 96 which extends into the recess 98 inside coupler 10 andwhich is secured therein by threads 100 cooperating with ribs or threads36 on the interior of the coupler 10. In the embodiment shown, cylinder40 has a tapered outer surface 102 which causes a wedging action withthe interior of connector 96 as indicated at 104, such that as theconnector 94 is turned and threaded into the recess 98 the cylinder 40and connector 96 are tightly wedged together sealing against any loss offluid. Alternatively both cylinder 40 and connector 96 can be straightwith parallel surfaces, and they can be secured together by an adhesive,such as a solvent adhesive, as shown at 97 in FIG. 15.

Preferably the design of the tapered cylinder 40 and connector 96 aresuch that the end 106 of cylinder 40 and the opposing surface 108 on theinterior of connector 96 are closely adjacent or abutting such that thespace 110 between them is minimized.

Connection of the device of this invention to tubing 48 or any otherdevice may be configured to be releasable or permanent, as desired. Inthe embodiment shown, the connector has at its opposite end a nipple 112to which the conventional tubing 48 is attached. The tubing is normallystretched slightly as indicated at 114 so that the tubing 48 is retainedon the nipple 112 by the combination of the elastic resiliency of thetubing and the interference fit between the inner surface of the tubing48 and the outer surface of the nipple 112. If there is concern that thetubing 48 may separate from the nipple 112, a conventional externalclamp (not shown) may be placed around the circumference of the tubing48 where it overlaps the nipple 112 and tightened to ensure goodconnection between the tubing and the nipple. Alternatively variousadhesives or solvents may be used to secure the tubing and nippletogether. The solvents or adhesives must be selected such that they donot intrude into the fluid flow path of the device or migrate to causeunwanted adhesion elsewhere in the device.

Activation and deactivation of the valve 2 will be best understood bycomparison of FIGS. 7 and 8. The device in its deactivated configurationis shown in FIG. 7, with the plug 6 in its “rest” or fully resiledorientation. (For purposes of comparison, it will be understood thatconnector 94 and tubing 49 of FIG. 8 should be imagined also to bepresent in FIG. 7.) Activation comprises joining of the needleless valve2 to a liquid supply source such as a syringe or other reservoir device,partially shown at 116 in FIG. 8. Connection is usually through acoupler 118 which is similar in configuration to the coupler 10 of thevalve. Coupler 118 consists of an outer cylindrical wall 120 which hason its inner side ribs or threads 122. Aligned with the center axis ofcoupler 118 is nozzle 90 which extends outwardly from the end 124 ofcoupler 118 and which is tapered to fit into the receiving portion 126of section 28 of the housing 8. The interior of nozzle 90 is an openfluid flow channel 128 which is in fluid communication with the interior130 of liquid reservoir 116. The reservoir 116 is here illustrated as aconventional syringe device, with a movable piston 132 housed within acylinder 130. The piston 132 is manipulated by the physician or nurse asindicated by the arrow 50 to force the liquid forward. Such use andoperation of the fluid dispensing device 116 are conventional and neednot be described further. Similarly, such devices may take manydifferent forms, all of which are equally applicable to the presentinvention.

As the coupler 118 is moved forward (as indicated by the arrow 134) byinteraction of the threads 32 and 112, the tapered nozzle 90 interactswith the inner surface 136 of the receiver section 126 of the housing tocreate a wedging action similar to that described above between theconnectors 94 and 10, thus forming a mechanically tight connection.Simultaneously the front end 138 of coupler 118 comes into contact withdistal end surface 20 of plug 6 and forces the plug 6 to compress in thedownstream or proximal direction, thus causing the slit 22 to contactthe tip 64 of rod 14 and be forced open as it passes over and around thetip 64, as best illustrated in FIG. 11. The compressive movement of therest of the plug 6 caused by the forward motion of the nozzle 90 causesthe other portions of the plug 6 to move along corresponding sections ofthe rod 14 and ribs 86 (and 86′, if present), thus forcing the wall ofthe plug 6 to be stretched and expanded outwardly, substantiallyincreasing the interior volume of the plug 6 and creating the space 82through which the fluid can flow along the surfaces of rod 14 and ribs86. With the plug 6 thus retracted, the liquid can flow freely from theliquid reservoir or supply device 116 through the nozzle 90 and thenow-opened slit 22, along and adjacent to the outer surfaces of the rod14 and ribs 86 (through the elongated V-shaped spaces 82 formed byadjacent ribs 86, the rod 14, and the inner surface of the plug 6, andon through the openings 146 and into the conduits 46, 42 and 38, onthrough the channel 140 in the nipple 112 and into the interior 142 oftubing 48, and subsequently to the patient or other receiver.

Because the liquid source 116 and the valve 2 are securely lockedtogether by the interaction of threads 32 and 112 and the wedging actionof the receiver 126 and nozzle 90, this activated configuration isstable and can be maintained for as long as the physician, nurse orother user wishes to continue dispensing the liquid. It can also, ofcourse, be maintained for an extended period of time without humansupervision or control, where the reservoir or liquid supply device 116is mechanically or electrically operated and provides a continuous orintermittent flow of fluid through the valve 2 to the patient orreceiver.

In prior art devices, the flexible plug merely slid along the outside ofthe tubular cannula. Since the cannula had a uniform diameter, the plugremained strongly compressed over substantially all of its length, beingstretched or expanded only at the distal tip, and then only by theminimal amount necessary to open the end slit and allow the end of thehollow cannula to protrude into the nozzle of the fluid dispensingdevice. As the nozzle of the dispensing device was subsequentlywithdrawn and the plug allowed to resile back in the distal directionalong the outer surface of the cannula and closed over the open end ofthe cannula, a partial vacuum was created in the cannula. This in turncommonly resulted in liquid being withdrawn from the patient or receiverand pulled by suction back into the catheter to which the cannula of theprior art device was connected. Where the receiver was a human patient,the fluid drawn back into the cannula would usually consist in whole orin part of venous blood. The blood thus retained in the cannula wouldthereafter often congeal and coagulate, causing blockage of the hollowinterior cannula and making subsequent administration of fluid difficultor impossible until the valve and cannula were either replaced orcleaned.

FIG. 8 illustrates the improvement of the present invention in whichsuch creation of partial vacuum is entirely avoided and the self-purgingproperty of the device is illustrated. The plug, by being stretched toincrease the interior volume during activation, resiles and decreasesthat volume during deactivation, so that the contraction of the plugwall into the space 82 (essentially eliminating space 82) displacessubstantially all residual fluid remaining within the valve upondeactivation, and forces it to be expelled through the exit conduits. Inaddition, the resiling of the plug wall often creates a transientoverpressure which also assists in expulsion of the residual fluid.Since the plug ultimately resiles back to its rest configuration theoverpressure decreases to neutral pressure. Because the center member ofthis device is solid rod 14 rather than an open cannula, the end 20 ofresiling plug 6 passes over distal end 64 of rod 14 and slit 22 closesbefore the decrease in interior volume, and therefore purging action ofthe resiling plug, is completed. Consequently, unlike in the prior artvalves, no negative pressure is formed by the movement of end 20 and theclosing of slit 22.

The self-purging and pressure-creating operation of the device isevident from FIG. 8. As the nozzle 90 is withdrawn from the receiver,section 18 of plug 6 which has been under compression and has beenstretched and expanded over the ribs 86 of the rod 14, begins to resileand return toward the configuration shown in FIG. 7. This causes thespace 82 to be closed, completely or substantially, and all fluid whichhas been in that space is thus forced through openings 146 into conduit46 and on through to conduits 42, 38, 140 and 142 and into the receiveror patient, leaving no significant amount of fluid remaining in thevalve, as will be evident by comparison of FIGS. 9 and 10. This is theexact opposite of the operation the prior art devices, where return ofthe plug to the deactivated position has no effect on the interiorvolume of the cannula, since the cannula is made of a rigid plastic orsimilar material and therefore is not deformed by pressure from theplug. Thus the liquid remaining in the interior of the cannula cannot bepurged by the return of the plug to its deactivated position. In thepresent invention, by contrast, the resiling or return of the plug toits deactivated position forces the remaining fluid in the valvedownstream to the receiver or patient.

In most cases, the return and closing action of the plug 6 (or 6′) willbe adequately accomplished entirely by the resiliency of the elasticmaterial forming the plug, such that no outside biasing or urging of theplug is necessary. However, if desired, one could supplement the normalresiliency of plug 6 by, during assembly of the device, filling thespace 80 with an inert gas 144 such as nitrogen or argon, preferablyunder pressure. Thus, as the device is activated and the wall of theplug 6 is forced to expand outwardly by the rod 14 and ribs 86, itencounters the compressed gas within the space 80 and, while reducingthe volume of space 80, compresses (or further compresses) the gas 144.Consequently, when the device is deactivated, the compressed gas 144acts on the outside surface of the plug 6 and as the volume of chamber80 begins to increase (and space 82 decrease), the pressure of theexpanding gas supplements the normal resiliency of the plug 6 material,causing the device to purge itself more quickly and completely. Theexpanding compressed gas 144 forces the plug material to assume theconfiguration shown in FIG. 9 more completely, with closer fittingbetween the interior wall of the plug 6 and the exterior surface of therod 14 and ribs 86. The same effect will be seen by comparison of FIGS.14 and 16 for the embodiment of the rib 6′ shown in FIG. 12, involvingspaces 80 and 92. (One could also achieve the same effect by mechanicalrather than pneumatic action if one were to emplace small springs (notshown) within space 82 and in contact with the outer surface of the plugwall and the inner surface of the housing wall, and which would becompressed when the plug 6 expanded. Upon deactivation, the compressedwould then resile and expand, urging the plug wall inward and assistingin decreasing the interior volume of the plug.

It will thus be seen that, unlike prior art devices in which the fluidflow channel through the valve has a fixed volume within a cannula, thedevice of the present invention with its variable volume flow pathformed by the interaction of the center rod and ribs and the expandingand contracting interior dimension of the plug, employs a uniqueself-purging and pressure-generating action that causes essentially allof the fluid to be forced into the receiver or patient. This not onlykeeps the valve from being clogged by return flow of blood or otherreceiver fluid, but also ensures that substantially all of the dosage ofthe fluid intended for the patient or receiver is, in fact,administered, with no signficant amounts retained or lost within thevalve structure itself.

For brevity, the device and its operation have been described herein interms of administration of IV fluid or similar medications to a humanpatient. However, it will be evident that this valve also has numerousother uses in related medical areas, such as administration ofmedications or nutrients through the gastrointestinal system of apatient. It also has many uses outside the medical field, such asadministration of small quantities of liquid reactants or reagents inchemical or biological or medical testing procedures, or in the preciseadministration and delivery of chemical reactants in processes toproduce small quantities of specialty chemicals. Other uses may includeprecise delivery of standard fluids for calibration of test instrumentsor for conducting hydraulic or other fluid flow experiments or smallscale production processes.

It will be evident to those skilled in the art that there are numerousembodiments of the present invention which, while not expresslydescribed above, are clearly within the scope and spirit of theinvention. The above description is therefore intended to be exemplaryonly and the scope of the invention is to be determined solely from theappended claims.

1. A needleless valve comprising a tubular housing having a fluid inletend and a fluid outlet end, a soild rod within said housing, and ahollow flexible plug within said housing and moveable along said rod,said hollow plug in response to insertion of a fluid supply nozzle intosaid inlet end moving in one direction along and cooperating with saidrod to increase the volume of the interior of said plug and open a fluidflow path between said inlet and outlet ends, and in response towithdrawal of said fluid supply nozzle from said inlet end moving in anopposite direction along and cooperating with said rod to decrease thevolume of said plug interior, close said fluid flow path between saidinlet and outlet ends and cause residual fluid in said flow path to beexpelled from said valve through said outlet end.
 2. A needleless valveas in claim 1 further comprising said rod being elongated coaxially ofsaid valve and having a plurality of longitudinal ribs extendingoutwardly therefrom, said ribs cooperating with said plug in saidincrease in said interior volume and in said decrease in said interiorvolume.
 3. A needleless valve as in claim 2 wherein the distance a ribextends outwardly from said core varies over the length of said rib. 4.A needleless valve as in claim 3 wherein the distances of outward extentof said rib varies continuously over the length of said rib.
 5. Aneedleless valve as in claim 3 wherein the distances of outward extentof said rib varies discontinuously over the length of said rib.
 6. Aneedleless valve as in claim 2 further comprising said ribs terminatingadjacent said outlet end in a hollow annular member encircling said rod.7. A needleless valve having a distal end and a proximal end, andcomprising: a base disposed at said proximal end and comprising aconnector for fluid communication attachment to a fluid flow tube, asolid elongated fluid channeling rod extending from a proximal endjoined to said base to a distal end, and a fluid flow conduit formed insaid base and extending through said connector into said proximal endsaid rod and disposed for said fluid communication with said tube; aflexible plug having a wall forming a hollow interior bounded by aninward facing surface; said plug fitting over said rod, being sealinglyattached to said base and being moveable along said rod between a firstactivated position position and a second deactivated position; in saidfirst activated position said rod maintaining said plug in a form withsaid interior having a first larger volume, with said plug withdrawnfrom said distal end of said rod, and creating a fluid flow path throughsaid interior and along said rod; and in said second deactivatedposition said plug being in a form with said interior having a secondsmaller volume with said distal end of said rod covered by said plug andsaid fluid flow path being blocked by said wall of said plug; and atubular housing fitting over said plug and extending from said distalend of said device to said base, at said distal end said housing havingan elongated receiver for releasable fluid communication reception of anozzle of a fluid source, said receiver configured to guide movement ofsaid nozzle along said receiver into contact with said plug, said plugmoving between said first and said second positions in response tomovement of and contact from said nozzle; such that movement of saidplug from said first position to said second position in response toinsertion of said nozzle into said receiver causing said rod and saidplug to cooperate to expand said plug and increase said interior volumeand open said valve to fluid flow between said source and said tube, andsubsequent movement of said plug from said second position to said firstposition in response to withdrawal of said nozzle from said receivercausing said plug to resile and said interior volume to decrease,closing said valve to said fluid flow, displacing residual fluid withinsaid valve and causing said residual fluid to flow from the proximal endof said valve into said tube.
 8. A needleless valve as in claim 7further comprising said rod being elongated coaxially of said valve andhaving a plurality of longitudinal ribs extending outwardly therefrom,said ribs cooperating with said plug in said increase in said interiorvolume and in said decrease in said interior volume.
 9. A needlelessvalve as in claim 8 wherein the distance a rib extends outwardly fromsaid core varies over the length of said rib.
 10. A needleless valve asin claim 9 wherein the distances of outward extent of said rib variescontinuously over the length of said rib.
 11. A needleless valve as inclaim 9 wherein the distances of outward extent of said rib variesdiscontinuously over the length of said rib.
 12. A needleless valve asin claim 8 further comprising said ribs terminating adjacent said outletend in a hollow annular member encircling said rod.
 13. A needlelessvalve as in claim 7 wherein said cooperation between said rod and saidplug as said plug interior decreases in volume creates a transientpositive pressure against residual fluid enhancing said expulsion ofsaid fluid from said valve into said tube.
 14. A needleless valve as inclaim 7 wherein said flexible plug is formed of a resilient material.15. A needleless valve as in claim 7 further comprising an interiorsurface of said housing adjacent said proximal end forming a chambersurrounding said rod and a portion of said plug, said chamber beingfilled with gas, such that said expansion of said plug into said chambercauses compression of said gas, said compressed gas thereafter acting toenhance resiling of said plug and decrease of said interior volume. 16.A needleless valve as in claim 7 wherein said plug comprises an expandedproximal section which upon activation enhances the degree of expansionof said interior volume.
 17. A rod for a needleless valve comprising anelongated core having a plurality of longitudinal ribs extendingoutwardly therefrom.
 18. A rod for a needleless valve as in claim 17wherein the distance a rib extends outwardly from said core variescontinuously over the length of said rib.
 19. A rod for a needlelessvalve as in claim 17 wherein the distance a rib extends outwardly fromsaid core varies discontinuously over the length of said rib.
 20. A rodfor a needleless valve as in claim 16 further comprising said ribsterminating adjacent said outlet end in a hollow annular memberencircling said rod a solid elongated core having a plurality of coaxialribs extending outwardly therefrom.